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Journalist's Resource: How to Spot Bias in Randomized Clinical Trials

Journalist’s Resource, a news source based at Harvard University's Shorenstein Center on Media, Politics and Public Policy, recently wrote about how to spot bias in randomized clinical trials. The article was based on a presentation given by Joanna Chikwe, MD, chair of the newly established Department of Cardiac Surgery in the Smidt Heart Institute, during a meeting with fellows from the National Press Foundation.

Chikwe began her presentation by explaning that randomized, controlled clinical trials are studies in which a new intervention, such as a medical device or medication, is randomly assigned to some participants and tested against a control group, participant who receive a standard treatment. Outcomes are then compared. 

And while they are often considered the gold standard of medical research, Chikwe, who serves as chair of the newly established Department of Cardiac Surgery in the Smidt Heart Institute at Cedars-Sinai, told fellowship participants that journalists cannot assume a study or trial is reliable just because it’s randomized.

That’s because, Chikwe says, there is often a cost-benefit to the healthcare source responsible for developing or testing a trial.

“Innovation is one of the biggest cost drivers,” said Chikwe. “It will take you, on average, between $7 million and $19 million just to go from concept to a medical device that’s ready to put into a person,” Chikwe told participants. “And that’s the cheap bit, one randomized trial is required for U.S. Food and Drug Administration approval, and that will cost you somewhere between $31 million and $95 million.”

During her talk, which focused on medical device development, Chikwe explained how the cost of industry innovation can influence the results of clinical trials. Chikwe also highlighted a few strategies that trials might employ in hopes of securing favorable results — and questions journalists can ask to help them detect when these strategies are being used.

Click here to read more commentary from Chikwe during her National Press Foundation presentation.

Read more on the Cedars-Sinai Blog: Matters of the Heart: Joanna Chikwe, MD